Quality and Regulatory

Regulatory submissions

Regulatory submissions can sometimes feel daunting. We see it as part of our job to help you navigate through this process.

Your product will be developed and manufactured in accordance with all applicable regulatory guidelines. We carefully establish and maintain Design History Files, the Device Master Record, the Technical file, and provide Risk Management Files.

With decades of experience in regulatory submissions, we can if needed, assist with regulatory strategy and submissions. This can include technical files under the Medical Device Directive 93/42/EEC and FDA 510(k).